TRIMEZOL. 480 mg. 20 tablets
Trimezol should be used in cases where, by decision of the physician, the benefits of treatment outweigh any potential risks.
Susceptibility of bacteria to antimicrobial agents varies geographically and over time, and this should always be taken into account in the choice of antibacterial therapy.
TRIMEZOL. 480 mg. 20 tablets
What Trimezol and what it is used
Trimezol antibacterial drug that works by killing bacteria that cause infections.
Trimezol should be used in cases where , by decision of the physician, the benefits of treatment outweigh any potential risks.
Susceptibility of bacteria to antimicrobial agents varies geographically and over time , and this should always be taken into account in the choice of antibacterial therapy .
The product applies to:
Treatment and prevention of pneumonia in adults and children caused by the agent P. carinii ( Pneumocystis Carini pneumonia characteristic of patients with AIDS) ;
Treatment and prevention of toxoplasmosis ;
Treatment of nocardiosis ( type of bacterial infection , leading to the formation of abscesses ) ;
Treatment of urinary tract infections ;
Exacerbation of chronic bronchitis where there is evidence of susceptibility of bacteria to the two active ingredients of the drug and there is good reason to prefer the combination to monotherapy with an antibiotic ;
Treatment of acute otitis media when there is good reason to prefer the combination over monotherapy antibiotic.
2 . What you should know before you apply Trimezol
Do not take Trimezol :
If you are allergic (hypersensitive) to trimethoprim, sulfonamides, or any of the other ingredients of the product (see section 6) ;
If you have severe liver disease or significant liver damage and jaundice ;
If you have severe blood disorder porphyria, or ill ;
If you have severe renal insufficiency, in which can not be made necessary in the treatment studies;
Trimezol not be used in infants during the first 6 weeks , except for cases of treatment / prophylaxis of pneumocystosis in children over the age of 4 weeks.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Trimezol :
If you have severe allergies and asthma ;
If you suffer from phenylketonuria and dieting ;
If you have a deficiency of glucose- 6-phosphate dehydrogenase ;
If you are elderly ;
If you have elevated blood potassium ;
If you have kidney failure,
If you have folic failure;
If you are going creatinine in the blood.
Trimezol therapy should be discontinued immediately at the first appearance of skin rash.
When using sulfamethoxazole reported occurrence of potentially life-threatening skin rashes (Stevens -Johnson syndrome, toxic epidermal necrolysis) , which initially appear as red , sharp target or circular patches often with blisters in the center ;
Additional features that can be observed are: ulcers in the mouth, throat , nose and genitals conjunctivitis ( red and swollen eyes ) ;
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling ( peeling ) of the skin;
Highest risk for serious skin reactions exist in the first weeks of treatment ;
If after administration of sulfamethoxazole have developed Stevens -Johnson syndrome or toxic epidermal necrolysis more should never be treated with sulfamethoxazole ;
If you experience skin rash or these symptoms , seek medical advice immediately and inform them that you are taking this medicine.
In patients on chronic treatment, the doctor will order blood tests at monthly intervals.
Continued use of the product may suppress the normal intestinal flora and cause of severe colitis . If severe disorder , treatment should be discontinued and appropriate treatment administered .
Other medicines and Trimezol
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Tell your doctor if you take:
Anticoagulants ( funds that inhibit blood clotting , such as warfarin and acenocoumarol ) ;
Antidiabetic sulfonylurea agents such as glibenclamide, glipizide , gliclazide , glimepiride ) ;
Antiepileptics ( phenytoin) ;
Digoxin (used to treat heart failure) ( important for the elderly ) ;
Thiazide diuretics ( water pills such as indapamide , hydrochlorothiazide , chlorthalidone ) ( important for the elderly ) ;
Anesthetics ( anesthetic , eg . Prilocaine ) ;
Antibacterials (especially dapsone , methenamine , rifampicin) ;
Antifolate drugs ( suppressive effect of folic acid , e. Dapsone daraprim , sulfadiazine , sulfitren ) ;
Antimalarial drugs ( especially pyrimethamine at doses above 25 mg per week ;
Antiviral agents ( lamivudine , zidovudine ) ;
Drugs which are cations at physiological pH (e.g., procainamide , amantadine ) ;
Clozapine (for the treatment of schizophrenia and psychosis ) ;
Cytotoxic drugs ( methotrexate) ;
Immunosuppressants (cyclosporine ) ;
Laboratory tests - reported that affect Trimezol diagnostic tests , incl. fixing of methotrexate in the blood in the study of urea and creatinine, and urine glucose testing and urobilinogen .
Trimezol of food, beverages and alcohol
Trimezol preferably be taken with food or liquid to reduce stomach irritation.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
Trimezol should not be used during pregnancy since safety in pregnancy has not been established. The product influences folate metabolism and may have teratogenic effects if used in the first trimester.
When applied in the last three months of pregnancy Trimezol may cause destruction of red blood cells and fetal methemoglobinemia , and if given before birth may occur brain damage from free bilirubin ( kernicterus ) due to displacement of bilirubin . In neonates may occur and other toxicities , such as jaundice and haemolytic anemia . The risk of kernicterus is higher in children with an increased risk of hyperbilirubinemia , as patients stressed prematurity or those deficient in glucose -6- phosphate dehydrogenase .
Trimezol is excreted in breast milk in small amounts. However, the risk of kernicterus if children are at increased risk of hyperbilirubinemia .
Driving and using machines
Since Trimezol may cause confusion, dizziness , tinnitus , insomnia and hallucinations, patients should be assured that these symptoms did not occur to them before driving or operating machinery .
Trimezol contains wheat starch
It is suitable for people with celiac disease (gluten enteropathy ) . Patients with wheat allergy ( different from celiac disease ) should not take this product.
3 . How to use Trimezol
Treatment continues for at least 2 days after symptoms have resolved , in most cases require treatment for at least 5 days. If it is not shown improvement after 7 days of treatment, therapy should be considered again.
The usual dose for adults and children over 12 years is 2 tablets every 12 hours. In severe infections, the dose may be increased to 6 tablets daily, taken 2 times.
For the treatment of pulmonary infections caused by Pneumocystis carinii , the dose is 80 - 100 mg/kg/24 h , and sulfamethoxazole 16-20 mg/kg/24h trimethoprim, divided into 3-4 administered for 14-21 days. For prophylaxis of the same disease , the dose is :
2 tablets a day for 7 days, or
2 tablets a day three times a week during the day or
2 tablets 2 times a day 3 times a week during the day.
The usual dosage for children is 30 mg/kg/24 h sulfamethoxazole and trimethoprim 6 mg/kg/24 h divided in two single doses . For children from 5 to 12 years - 1 tablet every 12 hours.
In children under 5 years are recommended for use Trimezol oral suspension .
Treatment of nocardiosis - Six to eight tablets per day for 3 months.
Treatment and prevention of toxoplasmosis - dose as for the prevention of pneumocystosis .
Apply adult dose. These patients are more susceptible to side effects , and is more likely to develop serious disorders, especially when there are complicating circumstances as impaired renal or hepatic function , or concomitant use of other drugs. This requires caution.
Patients with renal insufficiency
Patients over 12 years with renal impairment following doses are recommended :
Creatinine clearance (ml / min)> 30 - Standard dose ;
Creatinine clearance (ml / min) 15 30 - half the recommended dose ;
Creatinine clearance (ml / min) < 15 - Not recommended.
It is recommended that the measurement of plasma concentrations of sulfamethoxazole at intervals in two or three days, 12 hours after taking the product . If the concentration of total sulfamethoxazole exceeds 150 ?g / ml, treatment should be withheld until the fall of its values below 120 .
If you take more dose Trimezol :
Acute overdose can be observed loss of appetite , nausea, cramps, vomiting , confusion, disorientation . Possible onset of fever and crystalluria . Later manifest jaundice and changes in the blood picture. According to the degree of overdose should be considered gastric lavage , forced diuresis , administration of sodium bicarbonate and folic acid, in severe cases - hemodialysis.
Upon continued administration of high doses may be observed symptoms of chronic overdose - suppression of bone marrow function (thrombocytopenia , leucopenia, megaloblastic anemia ) . For treatment applied plenty of fluids to maintain urine output of calcium leucovorin 5 to 15 mg daily and calcium folinate 3-6 mg for 5-7 days orally or intramuscularly.
If you forget to take Trimezol
If you forget to take your medicine , take it as soon as possible or you miss a dose if it is time to take the next . Do not take a double dose to make up for a missed dose. If you forget or think that you have missed several doses , you should contact a doctor.
4 . Possible side effects
Like any other medicine, Trimezol can cause effects, although not everybody gets them .
Adverse reactions are classified according to event as follows : very common (> 1/10 ), common (> 1/100 , <1 /10) > uncommon ( > = 1/ 1000 , <1/ 100) rare (> 1/10 000, < 1/1 , 000), very rare ( <1/ 10, 000) .
Infections and infestations:
Common: candidiasis (fungal infection).
Blood and lymphatic system disorders:
Very Rare : leukopenia ( reduction in the number of white blood cells , which increases the possibility of the occurrence of an infection ) , a reduced number of blood neutrophils (a type of white blood cell) , a reduction in the number of blood platelets, which increases the risk of bleeding and bruising , agranulocytosis ( a severe reduction in the number of white blood cells , increasing the likelihood of infection ) , megaloblastic anemia ( in vitamin B12 deficiency ) , aplastic anemia ( strongly reduced number of blood cells, which leads to weakness , bruising or an increased likelihood of the occurrence of infections), hemolytic anemia (decreased numbers of red blood cells which can lead to a pallor or yellowing of the skin , weakness, or shortness of breath ) , methemoglobinemia (a condition of the blood to form an abnormal hemoglobin) eosinophilia ( elevated levels of eosinophils in the blood) , purpura (Minor hemorrhages in the skin and mucous membranes ) , haemolysis (breakdown of red blood cells ) in certain patients with deficiency of the enzyme glucose-6- phosphate dehydrogenase) .
Most of blood disorders are mild and reversible upon cessation of treatment. The majority of the changes do not cause clinical symptoms , but in isolated cases they can cause severe reactions , particularly in the elderly , in patients with liver or kidney failure , or with low levels of folic acid .
Immune system disorders :
Very rare: serum sickness , anaphylaxis (severe life-threatening reaction) , allergic myocarditis (inflammation of heart muscle) , angioedema (swelling of soft tissues of the face, tongue , throat ) , drug fever , allergic inflammation of vessels ( purpura Henoch - Schonlein purpura ) , autoimmune diseases ( periarteriitis nodosa, systemic lupus erythematosus ( erythematosus ) ) .
Metabolism and nutrition disorders:
Very common: a high content of potassium in the blood ;
Very rare: low sodium and blood sugar, blood acidification , loss of appetite .
Treatment with high doses , especially in elderly patients , requires careful monitoring , as these patients are more sensitive to manifestations of disordered salt balance in the blood.
Very rare: depression , hallucinations .
Nervous system disorders :
Common: headache ;
Very rare: non-infectious inflammation of the meninges (fast reversible upon discontinuation of therapy ) , convulsions , inflammation of the peripheral nerves , impaired balance , dizziness .
Ear and labyrinth disorders:
Very rare: dizziness , ringing in the ears.
Eye disorders :
Very rare : inflammation of the eye, causing pain and redness.
Respiratory disorders :
Very rare: cough, shortness of breath, pulmonary inflammation. It is possible that these signs are early symptoms of pulmonary hypersensitivity , in very rare cases may be fatal.
Common: nausea , diarrhea ;
Uncommon : vomiting ;
Very rare: inflammation of the tongue , inflammation of the oral mucosa , pseudomembranous colitis ( characterized by persistent and prolonged diarrhea , sometimes life-threatening ) , pancreatitis (inflammation of the pancreas ) .
Very rare: elevated liver enzymes and bilirubin , congestive jaundice, hepatic necrosis (sometimes fatal ) .
Skin and subcutaneous tissue disorders:
Common: skin rashes ;
Very rare: photosensitivity , exfoliative dermatitis ( redness and peeling of the skin), fixed drug eruption ( rash on the skin ) , severe allergic skin reactions, accompanied by blistering of the skin, mouth, eyes and genitals (erythema multiforme, potentially life-threatening skin reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis / syndrome Lyle / ) (see section 2 ) .
Musculo - skeletal system :
Very rare: pain in muscles and joints.
Renal and urinary disorders:
Very rare: renal function ( sometimes with renal failure ) , inflammation of the kidney tissue and the formation of crystals in the urine, which can be avoided by adequate fluid intake .
General disorders and administration site conditions:
Very rarely , high doses for the treatment of Pneumocystis carinii pneumonia in AIDS patients may experience symptoms such as rash , fever , neutropenia , thrombocytopenia, elevated liver enzymes , hyperkalaemia and hyponatraemia , which requires discontinuation of treatment.
If symptoms of suppression of bone marrow to be administered at a dose of calcium folinate 5 to 10 mg per day .
Repeated administration of trimethoprim / sulfamethoxazole in patients with AIDS can lead to severe hypersensitivity reactions , even following the acceptance range for several days. If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Trimezol
At temperatures below 25 º C !
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Trimezol
The active ingredients sulfamethoxazole and trimethoprim are .
The other ingredients are corn starch , cellulose, microcrystalline , magnesium stearate, hydroxypropylcellulose.
Trimezol looks like and contents of pack
Round, flat tablets with bilateral facet and scored on one side , with a diameter of 13 mm, white in color.
The tablet can be divided into two equal doses.
10 (ten) number of tablets in blister transparent orange PVC / Al foil ; 2 (two) blisters in a cardboard box.